DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 22, 2026 has been entered.
Claims 2-15, 17, and 20 have been canceled.
Claims 1, 16, 18, and 19 are pending and currently under consideration.
3. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
4. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
5. Claims 1, 16, 18, and 19 stand rejected under 35 U.S.C. 103 as being unpatentable over Kavanaugh et. al. (Kavanaugh 1, Arthritis Rheumatology. 2017, Vol 69(11), pages 2151-2161) in view of Kavanaugh et. al. (Kavanaugh 2, American College of Rheumatology. 2012, Vol 64(8), pages 2504-2517), and Mease (Arthritis Care & Research. 2011, 63;S11:S64-S85) as evidenced by the disclosure in the instant specification in page 78 that the heavy and light chain amino acid sequence of the anti-TNF antibody golimumab are SEQ ID NOs: 36 and 37, respectively, for the reasons of record.
Applicant’s arguments have been fully considered but have not been found persuasive.
Applicant argues that Kavanaugh 1 and Kavanaugh 2 and Mease alone or in combination do not teach or suggest each and every element of claim 1. While applicant does not seem to argue that the prior art administered the same anti-TNF antibody but asserts that Kavanaugh 1 does not teach or suggest administering for at least 52 weeks or measuring whether the patient has achieved the recited clinical metrics and prolonged dosing regimen and the long-term efficacy. Applicant further asserts that Kavanaugh 2 and Mease do not teach measuring efficacy based on remission-low disease activity based on a DAPSA score, inactive disease activity based on a PASDA score, remission based on CDAI score or a VLDA score or application of DAPSA for evaluating clinical efficacy in the context of the claimed method. In addition, Kavanaugh 2 only teaches subcutaneous administration. Applicant further argues that Mease states that many of the measures have not been officially validated in PsA nor have the specifics of performance characteristics been evaluated. As such, applicant asserts that the rejection should be withdrawn.
This is not found persuasive for following reasons:
Once again, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Here, Kavanaugh 1 teaches method of treating human adult patients suffering from active PsA by IV administration of the same anti-TNF antibody golimumab at a dose of 2 mg/kg at week 0 and 4, followed by IV administration of the antibody every 8 weeks at week 12 and week 20 and achieved significantly greater improvements in signs and symptoms of PsA and less radiographic progression through week 24 (e.g. see Conclusion in right col. in page 2151). Based on these results, Kavanaugh 1 specifically concludes that the treatment should be continue for 1 year (52 weeks). An ordinary skill in the art would have been motivated by Kavanaugh 1 to continue IV administration every 8 weeks with a reasonable expectation of success because this would be the natural extension of the two IV administrations at week 12 (8 weeks from week 4) and at week 20.
In addition, Kavanaugh 2 teaches treating adult human patient with active PsA with subcutaneous injection of the same anti-TNF antibody at weeks 0, 4, 8, 12, 16, and 20 weeks and maintained subcutaneous injection every 4 weeks from week 24 on to week 52. Kavanaugh 2 designed subcutaneous injection of the same anti-TNF antibody with regiment followed week 20 onto week 52 (every 4 weeks administration).
In contrast to applicant’s assertion that Mease teaches many of the measures have not been officially validated in PsA, note that Mease explicitly teaches DAPSA (Disease Activity in Psoriatic Arthritis, e.g. see Abstract). Mease further teach that there was growing interests managing PsA to achieve the goal of minimal disease activity or remission in order to maximize clinical improvement and minimize long-term damage (e.g. see left col. in page S64). Furthermore, Mease teaches that DAPSA measurement was tested in PsA patient starting a new disease-modifying drug treatment and was shown to be correlated highly with other measures including ADS28, Simplified Disease Activity Index, and Clinical Disease Activity Index in date set of a phase III clinical trial.
Therefore, the instantly claimed method encompassing every 8 weeks thereafter for at least 52 weeks after week 4 treatment followed by measuring DAPSA (known to have high discriminant capability) would have been obvious to one of ordinary skill in the art in the field of treating active PsA with the well-known anti-TNF antibody.
One of ordinary skill in the art would also be able to evaluate the outcome of the therapy by measuring the well-established clinical criteria for PsA including DAPSA as taught by Mease and Kavanaugh 2.
Therefore, applicant’s arguments have not been found persuasive.
6. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
7. Claims 1, 16, 18, and 19 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,041,020 (the ‘020 patent) in view of Kavanaugh et. al. (Kavanaugh 1, Arthritis Rheumatology. 2017, Vol 69(11), pages 2151-2161), Kavanaugh et. al. (Kavanaugh 2, American College of Rheumatology. 2012, Vol 64(8), pages 2504-2517), and Mease (Arthritis Care & Research. 2011, 63;S11:S64-S85) for the reasons of record.
Applicant argues that the instant claims are distinct from the claims in the ‘020 Patent in that the instant claims do not recite achieving at 14 weeks of treatment a mean change from baseline in HAQ-DI, enthesitis, dactylitis, SF-36PCS, or SF-36MCS in patient but rather measuring at week 52 to determine whether the patient achieved remission low activity based on score including DAPSA. Applicant asserts that the instant claims recite active measuring steps which was not recited in the conflicting claims. As such, applicant asserts that the rejection should be withdrawn. Applicant’s arguments and the Examiner’s rebuttal regarding the teachings of Kavanaugh 1, Kavanaugh 2, and Mease are essentially the same as discussed above.
As such, applicant asserts that the rejection should be withdrawn.
This is not found persuasive for following reasons:
In contrast to applicant’s arguments, note that the instant claims and the claims in the ’020 Patent are drawn to the same methods of treating PsA by intravenously administering the identical anti-TNF-α antibody.
Regarding 52 weeks of treatment, Kavanaugh 1 and 2 both teaches a 52-week clinical trial of golimumab in psoriatic arthritis (page 2505, Results). Although the reference is silent about the measuring the results such as DAPSA after 52 weeks, as stated above, Mease explicitly teaches DAPSA (Disease Activity in Psoriatic Arthritis, e.g. see Abstract). Mease further teach that there was growing interests managing PsA to achieve the goal of minimal disease activity or remission in order to maximize clinical improvement and minimize long-term damage (e.g. see left col. in page S64). Furthermore, Mease teaches that DAPSA measurement was tested in PsA patient starting a new disease-modifying drug treatment and was shown to be correlated highly with other measures including ADS28, Simplified Disease Activity Index, and Clinical Disease Activity Index in date set of a phase III clinical trial. Given that DASPA was a known metric in determining treatment effect as disclosed by Mease, and given that it was known that the anti-TNF-α antibody was shown in a 52-week clinical trial, it would be obvious to one of ordinary skill in the art to determine the DASPA after 52 weeks of treatment after the treatment methods as recited in the ‘020 Patent. As such, the claims in the ‘020 Patent would render the instant claims obvious.
Applicant’s arguments have not been found persuasive.
8. Claims 1, 16, 18, and 19 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of US 12,122,824 (the ‘824 Patent, matured from USSN 17/320,490) in view of Kavanaugh et. al. (Kavanaugh 1, Arthritis Rheumatology. 2017, Vol 69(11), pages 2151-2161), Kavanaugh et. al. (Kavanaugh 2, American College of Rheumatology. 2012, Vol 64(8), pages 2504-2517), and Mease (Arthritis Care & Research. 2011, 63;S11:S64-S85) for the reasons of record.
Applicant’s arguments and the Examiner’s rebuttal are essentially the same as discussed above.
9. Claims 1, 16, 18, and 19 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over amended claims 1, 2, 4-9, and 11-14 of copending USSN 17/423,512 (the ‘512 application) in view of Mease (Arthritis Care & Research. 2011, 63;S11:S64-S85) for the reasons of record.
Applicant’s arguments and the Examiner’s rebuttals are essentially the same as discussed above.
10. Claims 1, 16, 18, and 19 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-23 of copending Application No. 18/889,629 (the ‘629 application) in view of Kavanaugh et. al. (Kavanaugh 1, Arthritis Rheumatology. 2017, Vol 69(11), pages 2151-2161) and Kavanaugh et. al. (Kavanaugh 2, American College of Rheumatology. 2012, Vol 64(8), pages 2504-2517), and Mease (Arthritis Care & Research. 2011, 63;S11:S64-S85) for the reasons of record.
Applicant’s arguments and the Examiner’s rebuttals are essentially the same as discussed above.
11. No claim is allowed.
12. All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHUN DAHLE whose telephone number is (571)272-8142. The examiner can normally be reached Mon-Fri 6:30am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHUN W DAHLE/Primary Examiner, Art Unit 1641
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